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HHS/FDA RIN: 0910-AC55 Publication ID: Spring 2008 
Title: Positron Emission Tomography Drugs; Current Good Manufacturing Practices 
Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The proposed rule would adopt CGMPs that reflect the unique characteristics of PET drugs. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 212   
Legal Authority: PL 105-115, sec 121   
Legal Deadline:
Action Source Description Date
Final  Statutory    11/21/1999 
Timetable:
Action Date FR Cite
NPRM  09/20/2005  70 FR 55038   
NPRM Comment Period End  12/19/2005    
Final Action  08/00/2008    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Governmental Jurisdictions  Federalism: No 
Included in the Regulatory Plan: No 
RIN Information URL: www.fda.gov/cder/regulatory/pet  
RIN Data Printed in the FR: Yes 
Related RINs: Previously reported as 0910-AB63 
Agency Contact:
Brian L. Pendleton
Senior Policy Advisor
Department of Health and Human Services
Food and Drug Administration
Suite 3037 (HFD-7), Office of Policy, WO 32, Room 4250, 10903 New Hampshire Avenue,
Silver Spring, MD 20993-0002
Phone:301 796-4614
Fax:301 847-3541
Email: brian.pendleton@fda.hhs.gov